LYRICA- pregabalin capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)

Tilgængelig fra:

REMEDYREPACK INC.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

LYRICA is indicated for:LYRICA is indicated for: - Management of neuropathic pain associated with diabetic peripheral neuropathy - Management of postherpetic neuralgia - Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older - Management of fibromyalgia - Management of neuropathic pain associated with spinal cord injury LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.2)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LYRICA during pregnancy. To provide information regarding the effects of in utero exposure to LYRICA, physicians are advised to recommend that pregnant patients taking LYRICA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Reg

Produkt oversigt:

25 mg capsules: White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in: 50 mg capsules: White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in: 75 mg capsules: White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in: 100 mg capsules: Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in: 150 mg capsules: White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in: 200 mg capsules: Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in: 225 mg capsules: White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in: 300 mg capsules: White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in: 20 mg/mL oral solution: 16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure: Storage and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).

Autorisation status:

New Drug Application

Indlægsseddel

REMEDYREPACK INC.
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MEDICATION GUIDE
LYRICA (LEER-I-KAH)
(PREGABALIN)
CAPSULES, CV
LYRICA (LEER-I-KAH)
(PREGABALIN)
ORAL SOLUTION, CV
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 5/2019
Read this Medication Guide before you start taking LYRICA and each
time you get a refill. There may be
new information. This information does not take the place of talking
to your healthcare provider about your
medical condition or treatment. If you have any questions about
LYRICA, ask your healthcare provider or
pharmacist.
What is the most important information I should know about LYRICA?
LYRICA may cause serious side effects including:
•
serious, even life-threatening,
allergic reactions
•
suicidal thoughts or actions
•
swelling of your hands, legs and feet
•
dizziness and sleepiness
These serious side effects are described below:
•
Serious, even life-threatening, allergic reactions.
Stop taking LYRICA and call your healthcare provider right away if you
have any of these signs of a
serious allergic reaction:
•
swelling of your face, mouth, lips, gums, tongue, throat or neck
•
trouble breathing
•
rash, hives (raised bumps) or blisters
•
Like other antiepileptic drugs, LYRICA may cause suicidal thoughts or
actions in a very small
number of people, about 1 in 500. Call a healthcare provider right
away if you have any of these
symptoms, especially if they are new, worse, or worry you:
•
thoughts about suicide or
dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
If you have suicidal thoughts or actions, do not stop LYRICA without
first talking to a healthcare
provider.
•
Stopping LYRICA suddenly can cause serious problems.
MEDIC

Produktets egenskaber

LYRICA- PREGABALIN CAPSULE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LYRICA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LYRICA.
LYRICA (PREGABALIN) CAPSULES, CV
LYRICA (PREGABALIN) ORAL SOLUTION, CV
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Indications and Usage ( 1)
5/2019
Dosage and Administration, Adjunctive Therapy for Partial-Onset
Seizures in Patients 1 Month of Age
and Older ( 2.4)
5/2019
Warnings and Precautions, Dizziness and Somnolence ( 5.6)
5/2019
Warnings and Precautions, Concomitant Use with Opioids ( 5.13)
6/2019
INDICATIONS AND USAGE
LYRICA is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
( 1)
Postherpetic neuralgia (PHN) ( 1)
Adjunctive therapy for the treatment of partial-onset seizures in
patients 1 month of age and older ( 1)
Fibromyalgia ( 1)
Neuropathic pain associated with spinal cord injury ( 1)
DOSAGE AND ADMINISTRATION
For adult indications, begin dosing at 150 mg/day. For partial-onset
seizure dosing in pediatric patients 1 month of age
and older, refer to section 2.4. ( 2.2, 2.3, 2.4, 2.5, 2.6)
Dosing recommendations:
INDICATION
DOSING REGIMEN
MAXIMUM DOSE
DPN Pain ( 2.2)
3 divided doses per day
300 mg/day within 1 week
PHN ( 2.3)
2 or 3 divided doses per day
300 mg/day within 1 week.
Maximum dose of 600 mg/day.
Adjunctive Therapy for Partial-Onset Seizures in
Pediatric and Adult Patients Weighing 30 kg or
More ( 2.4)
2 or 3 divided doses per day
Maximum dose of 600 mg/day.
Adjunctive Therapy for Partial-Onset Seizures in
Pediatric Patients Weighing Less than 30 kg (
2.4)
_1 month to less than 4 years:_
3 divided doses per day
_4 years and older:_
2 or 3 divided doses per day
14 mg/kg/day.
Fibromyalgia ( 2.5)
2 divided doses per day
300 mg/day within 1 week.
Maximum dose of 450 mg/day.
Neuropathic Pain Associated with Spinal Cord
Injury ( 2.6)
2 divided doses per day
300 mg/day within 1 week.
Maximum dose of 600 mg/day.
Dose should be